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Compares treatment options for PSMA-Positive Progressive Metastatic Castration-Resistant...
Official title A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07311694
What this study is testing
What is HRS-4357 injection?
HRS-4357 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for psma-positive progressive metastatic castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;
- Male, aged ≥ 18 years;
- ECOG performance status score of 0-1;
- Expected survival time of no less than 6 months;
- Prostate adenocarcinoma confirmed by histology and/or cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with...
You likely can't join if
- Received any of the following treatments before randomization:
- Any radionuclide therapy or hemi-body radiotherapy within 6 months.
- Any PSMA-targeted radiopharmaceutical therapy.
- Surgery, radiotherapy, or any local therapy within 4 weeks.
- Any other investigational drug intervention within 4 weeks.
- Known hypersensitivity to the components of the study drug or its analogs.
See the full eligibility criteria
- Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;
- Male, aged ≥ 18 years;
- ECOG performance status score of 0-1;
- Expected survival time of no less than 6 months;
- Prostate adenocarcinoma confirmed by histology and/or cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with reference to current clinical guidelines;
- Presence of at least one metastatic lesion confirmed by imaging examinations (CT/MRI and/or bone scan) within 4 weeks before randomization;
- Confirmation of at least one PSMA-positive lesion and no PSMA-negative lesions by PSMA PET/CT;
- Serum testosterone at castration level (\< 50 ng/dl or \< 1.7 nmol/L) at the screening visit; continuous luteinizing hormone-releasing hormone analog (LHRHA) therapy (medical castration) or previous bilateral...
- Previous treatment with second-generation ARPIs, with only one episode of disease progression during treatment; and assessed by the investigator as suitable for switching to another ARPI (suitable for receiving...
- Disease progression at the time of enrollment. Disease progression is defined as the occurrence of at least one of the following while the subject's serum testosterone is at a stable castration level: ① PSA progression...
- Received any of the following treatments before randomization:
- Any radionuclide therapy or hemi-body radiotherapy within 6 months.
- Any PSMA-targeted radiopharmaceutical therapy.
- Surgery, radiotherapy, or any local therapy within 4 weeks.
- Any other investigational drug intervention within 4 weeks.
- Known hypersensitivity to the components of the study drug or its analogs.
- History of malignancy (other than prostate cancer) within 5 years before randomization that is expected to alter life expectancy or may interfere with disease assessment, excluding cured malignancies with low risk of...
- Occurrence of severe infection (CTCAE \> Grade 2) within 4 weeks before randomization.
- Failure to recover from adverse events of previous treatments (NCI-CTCAE Version 5.0 Grade \> 1) before randomization, as judged by the investigator.
- Presence of poorly controlled clinical cardiac symptoms or cardiac diseases.
- History of physical or psychiatric illnesses/conditions that may interfere with the study objectives and assessments (including epilepsy and dementia).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.